USPTO Patents Application 09655710

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria. Virginia 22313-1450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

09/655,710

09/05/2000

Suman Prcct Singh Khanuja

056859/0107

8287

22428 7590 03/31/2005

FOLEY AND LARDNER
SUITE 500
3000 K STREET NW
WASHINGTON, DC 20007

EXAMINER

COE, SUSAN D

ART UNIT

PAPER NUMBER

1654

DATE MAILED: 03/31/2005

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

Office Action Summarv

Application No.

09/655,710

Applicant(s)
KHANUJA ETAL

Examiner

Susan D. Coe

Art Unit
1654

The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 1 33).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1.704(b).

Status

1 )K Responsive to communication(s) filed on 21 January 2005 .
2a)S This action is FINAL. 2b)D This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quay/e, 1935 CD. 1 1 , 453 O.G. 213.

Disposition of Claims

4) ^ Claim(s) 1.5.6,9 and 10 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) D Claim(s) is/are allowed.

6) ^ Claim(s) 1. 5.6 , 9. and 10 is/are rejected.

7) Q Claim(s) is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) Q The specification is objected to by the Examiner.

10) D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a).
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1 .121(d).

1 1) D The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f).
a)D All b)D Some * c)D None of:

1 .□ Certified copies of the priority documents have been received.

2. Q Certified copies of the priority documents have been received in Application No. .

3. Q Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) □ Notice of References Cited (PTO-892)

2) O Notice of DraftspersorVs Patent Drawing Review (PTO-948)

3) □ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08)

Paper No(s)/Mail Date .

4) □ Interview Summary (PTO-413)

Paper No(s)/Mail Date. .

5) □ Notice of Informal Patent Application (PTO-152)

6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 1-04)

Office Action Summary

Part of Paper No./Mail Date 20050318 /

Application/Control Number: 09/655,710 Page 2

Art Unit: 1654

DETAILED ACTION

1. The amendment filed January 21, 2005, has been received and entered. The text of those
sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action.

2. Claims 1, 5, 6, 9, and 10 are pending.

3. The election of species requirement of April 21, 2001 is hereby withdrawn.

4. Claims 1, 5, 6, 9, and 10 are examined fully on the merits.

Claim Rejections - 35 USC § 112
Claims 1, 5, 6, 9, and 10 rejected under 35 U.S.C. 1 12, second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject matter which
applicant regards as the invention.

5. Claim 1 is indefinite because the phrase "said effective amount of said bioenhancer of
bioavailability facilitator" in line 6 lacks antecedent basis because applicant has cancelled the
phrase "an effective amount" from line 1 . In addition, the last two lines of the claim conflict
with (ii). The last two lines of the claim state that the therapeutic agent is not present in a
therapeutically effective amount; however, the phrase immediately following (ii) states that the
therapeutic agent is present in a therapeutically effective amount. This conflict is confusing and
indefinite because it is not clear what amount of the therapeutic agent are required by the claim.

6. Claim 9 is indefinite because it states that the anti-bacterial is agent is "selected from the
group comprising. . .". This is indefinite because of the use of the "comprising" language in this
context, this language implies that the group can have members other than A, B, and C without

Application/Control Number: 09/655,710 Page 3

Art Unit: 1654

defining what the other members may be. Therefore, the claim is not clear as to the definition of
the antibacterial agent.

7. No claims are allowed. However, the claims are deemed free of the prior art and would
be allowable if amended to overcome the above 1 12 2 nd rejections.

Applicant's amendment necessitated the new ground(s) of rejection presented in this
Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).

A shortened statutory period for reply to this final action is set to expire THREE
MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
MONTHS of the mailing date of this final action and the advisory action is not mailed until after
the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
however, will the statutory period for reply expire later than SIX MONTHS from the date of this
final action.

Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Susan Coe whose telephone number is (571) 272-0963. The
examiner can normally be reached on Monday to Thursday from 8:00 to 5:30 and on alternating
Fridays.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Bruce Campell, can be reached on (571) 272-0974. The official fax phone number
for the organization where this application or proceeding is assigned is (571) 273-8300.

Application/Control Number: 09/655,710
Art Unit: 1654

Page 4

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to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197
(toll-free).

Any inquiry of a general nature or relating to the status of this application or proceeding
can be directed to the receptionist whose telephone number is (571) 272-1600.

3-1 f - OS

Susan D. Coe
Primary Examiner
Art Unit 1654